The phrase appears to be a specific, internal file or code name associated with the European Medicines Agency (EMA) and its Good Pharmacovigilance Practices (GVP) . Specifically, this string is found in the metadata of the detailed guide regarding monitoring medical literature , which outlines the entry of relevant information into the EudraVigilance database. Purpose of the Guide
This guide is designed for to ensure they correctly identify and report Individual Case Safety Reports (ICSRs) found in medical literature. Key Components of the Guidance major_spz_x_dwie_belki_gwiazdka_konopie_prod_at...
: Formatting requirements for recording information in the EudraVigilance database, including author names and journal details in Vancouver style . Regulatory Context The phrase appears to be a specific, internal
: Specific details like gender or age must be present. Key Components of the Guidance : Formatting requirements
The document provides a structured workflow for processing adverse drug reaction (ADR) data:
: Clear identification of the substance or medicinal product involved.
: Establishes strict rules for what qualifies as a valid ICSR.